ISPE – Turkey Affiliate

2016 ISPE Europe Annual Conference

The 2016 ISPE Europe Annual Conference – Integrated Technology, Quality and Compliance Strategy for Effective Operations will bring together pharmaceutical, regulatory and technology experts from around the world in Frankfurt in 7-9 March 2016.

The conference will be initiated with executive speeches around the topics of operational excellence, continuous manufacturing and new regulations for pharmaceuticals and biopharmaceuticals and will continue with paralel tracks including GMP updates, facilities of the future, data integrity, risk management and innovative approaches for technical matters.

This two-and-a-half-day, must-attend, education conference will use best practice case studies to explore current technologies, regulatory requirements and will provide delegates with techniques for the evaluation and implementation of cutting-edge technologies. The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with interest in new solutions and experiences.

Details about the conference and registration form can be found in the following link:

Thanks from ISPE Philippines

Through the Tulak Tacloban project that ISPE Philippines had supported and ISPE Turkey Affiliate had also contributed after the Typhoon Haiyan hit the Philippines in 2013, 130 schoolchildren finished primary/elementary schooling at mobile schools and these same children are now volunteers in their own community for calamity awareness.

“A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey”
Seminar and 10th Anniversary Celebration / 03 December 2015

ISPE Turkey Affiliate’s seminar around the theme of “A Holistic Look at Pharmaceutical Industry on the 10th Anniversary of ISPE Turkey" and the cocktail was held on December 3, 2015 at Four Seasons Hotel Sultanahmet, Ýstanbul with the participation of delegates from the pharmaceutical industry, suppliers, academy and Turkish Medicines and Medical Devices Agency officials.

The presentations about Harmonization in GMPs, EU and PIC/S GMP Recent Changes were made by Dr. Vee Revithi, Turkish Medicines and Medical Devices Agency PIC/S Processes by Pharm. Gülþen Yýlmaz, Management of Generation Conflicts by Dr. Buket Aksu. Fatma Taman/ Chair of ISPE Turkey Affiliate, Dr. Ünsal Hekiman/ Founder and Honorary Chairman of ISPE Turkey Affiliate, Prof. Dr. Ahmet Araman/ Past Chair of Turkey Affiliate and Dr. Theodora Kourti/ ISPE Senior Vice President for Regulatory Affairs held a speech about the ISPE’s activities with regards to the 10th Anniversary of the Affiliate.

While the Affiliate’s achievements for the past 10 years and the targets for the future were presented through the introductory video; it was also announced that grants to support education set in the name of late Board Member Zehra Gürol will be spread out with the contributions of the Affiliate’s gold sponspors.

Following the presentation of plaques to our event sponsor BTS and Founder Board Members, our 10th Anniversary was celebrated by cutting the 10th year cake all together and enjoying the cocktail reception with live classical music with the participation of all our guests.

We wish to carry on our tradition of conducting groundbreaking projects with which we leave our mark on the future, in the next decades with the contributions of all our stakeholders...

Fatma Taman has been elected as Vice Chair for ISPE’s European Affiliates Council.

Ms. Fatma Taman has been elected as Vice Chair for ISPE’s European Affiliates Council for the term of 2015-2016, along with her Chair tenure at our Affiliate. Ms. Taman and our Secretary General Buket Hekiman Bayraktar took part at the ISPE Euroforum meeting, held in Munich on December 1 and contributed to the planning of ISPE’s future European projects.

ISPE Annual Meeting 2015

Our Chair Ms. Fatma Taman contributed to the ISPE Annual Meeting held on 8-11 November 2015 in Philadelphia-USA, with two presentations around the topics of “GMP in Aging Facilities” and “Implementation of Pharmaceutical Track & Trace System”. Ms. Figen Ergin (BTS) elaborated on quality management during the “GMP in Aging Facilities” presentation, while Mr. Timur Kabadayý (Conval) provided technical details for the validation aspect of Track & Trace Systems.

In addition, Our Chair Ms. Fatma Taman and our Secretary General Ms. Buket Hekiman Bayraktar took part at the Joint Affiliate Council Meeting, on behalf of our Affiliate.

ISPE Turkey Affiliate 2015 Fall Seminar
“Recent Developments in Quality by Design for Pharmaceutical Products”

ISPE Turkey Affiliate’s 2015 Fall Seminar around the theme of “Recent Developments in Quality by Design for Pharmaceutical Products” was held on October 15, 2015 at Point Hotel Barbaros, Ýstanbul. The seminar included presentations and case studies about the QbD impact on product develeopment, defining the quality target product profile, preparation for the regulatory submission, the dissolution test and clinically relevant spesifications as well as risk based approaches in the pharmaceutical development.

The speakers Dr. Paul Dickinson , Dr. Marcel de Matas and Dr. Buket Aksu held their presentations in an interactive workshop setting, which was very well received by the audience.


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